1. Technical Field
This device relates to biopsy needle devices used to obtain sample specimens of cells and tissue to be analyzed by a pathologist and more particularly to biopsy needle guides used to position the biopsy needle for insertion into the tissue to be sampled.
There are two types of specimens which can be given to the pathologist for analysis, one type is the core of tissue i.e solid tissue and the other is a collection of cells or cytology.
For prostate biopsies, pathologist are much more attuned to working with a core rather than the cytological specimen since the average pathologist working in the field has a difficult time interpreting the cytology specimen. It is therefore imperative to obtain a good core tissue specimen for analysis purposes.
To obtain a cytological specimen, an aspiration biopsy is performed by attaching a hollow needle to a syringe. The needle is then guided to the biopsy cite, for example, in the prostate by digital manipulation by the surgeon. The needle introduced to a predetermined depth into the tissue and a vacuum is then created by withdrawing the syringe, therefore aspirating the cell material required. In this form of biopsy, the needle is moved back and forth rapidly dislodging cells which are sucked into the needle. The fluid then obtained is ejected from the needle by removing the syringe from the needle filling the syringe with air and re-attaching the syringe to the needle. The air is then used to force the cells onto a glass slide where a smear is made of the fluid obtained.
The core of tissue sampling method which is preferred and to which this device is designed for utilizes a needle mechanism consisting of an outer needle with a sharp stylet within. It is critical in this type of core sampling that the biopsy needle not be bent beyond certain parameters since it interferes with the mechanism which is required to rapidly advance the outer needle over the stylet, sampling the core within.
Accordingly, it is the object of this invention to provide a semi-rigid core biopsy needle guide which can be positioned on the finger of the surgeon and inserted into the body cavity for proper biopsy needle operation.
2. Description of Prior Art
Prior Art devices of this type have relied on a variety of different guide elements and structures that are used in combination and rely on the physician's gloved finger for insertion and positioning procedures, see for example U.S. Pat. Nos. 4,022,191, 4,865,590, 4,892,520 and U.S. Pat. No. 4,991,592.
In U.S. Pat. No. 4,022,191 a biopsy needle guard and guide is disclosed for use with an aspiration biopsy needle device. The guard and guide has a rigid tapered tubular element, a portion of which is segmented by longitudinally spaced circumferential grooves. Dependent on the desired depth of insertion required, the appropriate segmented portion can be removed shortening the overall guide. The aspiration needle is inserted in sealing relation into the guide for use.
U.S. Pat. No. 4,865,590 discloses a disposable prostate aspiration device which is adhesively attached to the gloved finger of the physician. The device consist of a guide tube secured to a band of flexible support material such as adhesive tape. The tube extends outwardly beyond the support material. The tube is "loaded" with an antibiotic compound and provides a flexible guide for the aspiration needle. Insertion of the aspiration biopsy needle displaces the antibiotic compound within.
A finger mounted surgical needle guide is set forth in U.S. Pat. No. 4,892,520. The needle guide has a center needle support with outwardly extending wings to mount and stabilize the guide on a surgeon's finger. A pliable touch sensitive ribbon/attaching web extends from the distal end of the guide and extends around the end of the surgeon's finger.
In U.S. Pat. No. 4,991,592 a tissue sampling device is disclosed having a finger receiving tubular member with a flexible needle guide positioned within. The needle guide extends outwardly beyond the tubular member and has a tapered open end within the tubular member. A biopsy needle assembly is guided within the needle guide for use.